NCT07483190

Brief Summary

This study aims to investigate the effectiveness of a specific regional anesthesia technique, the Modified-Thoracoabdominal Nerve Block through a Perichondrial Approach (M-TAPA), on reducing pain after laparoscopic hysterectomy surgery. Hysterectomy is a common major surgical procedure, and managing postoperative pain is crucial for patient comfort and faster recovery. Participants will be randomly assigned to one of two groups: The M-TAPA Group: Patients will receive the nerve block using a local anesthetic (bupivacaine) before the surgery begins. The Control Group: Patients will receive standard postoperative pain management without the nerve block. The primary goal is to determine if the M-TAPA block reduces the total amount of opioid (morphine) used by patients in the first 24 hours after surgery. The researchers will also evaluate pain scores (NRS), the time until the first request for additional pain medication, patient satisfaction, and any side effects like nausea or vomiting

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
3mo left

Started Jun 2026

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Jun 2026Nov 2026

First Submitted

Initial submission to the registry

March 16, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 19, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

June 9, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2026

Last Updated

June 16, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

March 16, 2026

Last Update Submit

June 12, 2026

Conditions

Postoperative PainHysterectomyPlane Blocks

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    Total amount of morphine (mg) used via Patient-Controlled Analgesia (PCA)

    First 24 hours postoperatively

Secondary Outcomes (3)

  • Postoperative Pain Scores (NRS)

    Baseline (Hour 0), 1, 2, 4, 6, 12, and 24 hours postoperatively

  • Rescue analgesic drug consumption

    Within the first 24 hours postoperatively

  • Incidence of postoperative nausea and vomiting

    Within the first 24 hours postoperatively

Study Arms (2)

M-TAPA Group

EXPERIMENTAL
Procedure: Modified-Thoracoabdominal Nerve Block through a Perichondrial Approach (M-TAPA)

Control Group

NO INTERVENTION

Interventions

Modified-Thoracoabdominal Nerve Block through a Perichondrial Approach (M-TAPA)PROCEDURE

Under ultrasound guidance, a 22-gauge peripheral block needle is inserted at the costochondral angle (9th-10th ribs). After confirming the position, 20 ml of 0.25% bupivacaine is injected bilaterally into the lower part of the chondrium.

M-TAPA Group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly female participants are eligible for this study, as the research focuses on postoperative pain management following laparoscopic hysterectomy (surgical removal of the uterus). All participants are individuals scheduled for elective laparoscopic hysterectomy surgery under general anesthesia.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18 and 70 years
  • ASA (American Society of Anesthesiologists) physical status I, II, or III
  • Scheduled for elective laparoscopic hysterectomy
  • Voluntary participation with signed informed consent

You may not qualify if:

  • Hepatic or renal disease.
  • Coagulation disorders.
  • Uncontrolled cardiovascular or respiratory diseases.
  • Psychiatric disorders.
  • History of allergy to local anesthetics.
  • History of alcoholism, drug or substance abuse.
  • Body Mass Index (BMI) greater than 35 kg/m2
  • Refusal of the regional block procedure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istinye University Liv Hospital Bahcesehir

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

onur senyurt

CONTACT

+905520265992senyurtonur@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2026

First Posted

March 19, 2026

Study Start

June 9, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

November 15, 2026

Last Updated

June 16, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)